AsthmaPhase 4NCT00272753
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
A Phase 4 study testing budesonide/formoterol Turbuhaler, formoterol Turbuhaler and salbutamol in people with Asthma, run by AstraZeneca at 2 sites in Netherlands.
Trial summary
The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide/formoterol Turbuhaler, formoterol Turbuhaler and salbutamol
- How many people
- 20 participants
- Where
- 2 sitesNetherlands
- Study dates
- Apr 2004to Nov 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- asthma diagnosis according to ATS criteria,
- lung function (FEV1) above 60% of predicted,
- AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test
Who cannot join
- having smoked > 10 Pack-years,
- hypersensitivity to one of the study drugs,
- significant co-morbidity, pregnancy or lactating
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma
The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day
- Conditions
- Asthma
- Being tested
- budesonide/formoterol Turbuhaler, formoterol Turbuhaler, salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonide/formoterol TurbuhalerDrug
Also called Symbicort
formoterol TurbuhalerDrug
salbutamolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease in lung function (FEV1) after the third AMP provocation test.
Secondary outcomes (4)
Decrease in lung function (FEV1) after the second AMP provocation test,
lung function and Borg Score over the test day,
increase in FEV1 at three minutes after study drug inhalation,
time course of recovery from the AMP-induced decrease in lung function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startApr 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Netherlands Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272753
- Sponsor's protocol ID
- BN-00S-0022
- Status last verified
- May 2011
- First submitted
- 4 Jan 2006
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study. Respir Res. 2010 May 28;11(1):66. doi: 10.1186/1465-9921-11-66.
PubMed 20509942
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Comparison Between Single Doses of Symbicort Turbuhaler (Budesonide/Formoterol Combination), Formoterol, Salbutamol and Placebo in Repeated AMP-challenges in Patients With Mild - to Moderate Asthma. Investigating the Supplementary Value of the Budesonide Component Within Symbicort When Tested in a Model of Slow Onset Acute Asthma
- ClinicalTrials.gov ID
- NCT00272753
- Acronym / sponsor ID
- BN-00S-0022
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- asthma diagnosis according to ATS criteria,
- lung function (FEV1) above 60% of predicted,
- AMP-PC20 below 160 mg/ml with a documented fall in FEV1 of 30% in this provocation test
Key exclusion criteria (3 listed)
- having smoked > 10 Pack-years,
- hypersensitivity to one of the study drugs,
- significant co-morbidity, pregnancy or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonide/formoterol TurbuhalerAlso: Symbicort | Drug | – |
| formoterol Turbuhaler | Drug | – |
| salbutamol | Drug | – |
Primary outcome
The decrease in lung function (FEV1) after the third AMP provocation test.
4 secondary outcomes
Decrease in lung function (FEV1) after the second AMP provocation test,
lung function and Borg Score over the test day,
increase in FEV1 at three minutes after study drug inhalation,
time course of recovery from the AMP-induced decrease in lung function
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Derived from this study: PubMed 20509942Aalbers R, Boorsma M, van der Woude HJ, Jonkers RE. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study. Respir Res. 2010 May 28;11(1):66. doi: 10.1186/1465-9921-11-66.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AstraZeneca Netherlands Medical Director, MD study director
AstraZeneca
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide/formoterol Turbuhaler, formoterol Turbuhaler and salbutamol in people with Asthma, run by AstraZeneca at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease in lung function (FEV1) after the third AMP provocation test.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00272753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2011.